Enzyme
Food enzymes are reviewed by EFSA under EU Regulation (EC) No 1332/2008 and by FDA under GRAS or food-additive provisions. Each enzyme is evaluated case-by-case for safety, but the category as a whole is permitted with no general safety concern.
What it is
Industrial food enzyme — protein catalysts derived from plants, animals, or microorganisms (often via fermentation), added to food to perform technological functions in manufacturing.
Catalyzes specific reactions: dough conditioning (amylases, proteases), cheese making (rennet/chymosin), juice clarification (pectinases), brewing, lactose hydrolysis. Often functions as a processing aid, denatured by the time the food is consumed.
Why it's flagged
- Source-organism allergen disclosure required when relevant
- Each specific enzyme is evaluated individually; novel sources require separate authorization
What regulators actually say
"All food enzymes currently on the EU market and intended to remain on that market, as well as all new food enzymes, shall be subjected to a safety evaluation by EFSA and approval via an EU Community list."
"Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes ... the use of a food enzyme shall be authorised only if it does not pose a safety concern to the health of the consumer at the level of use proposed."
Regulatory status
United States — FDA
Generally regulated as GRAS or food additive depending on enzyme/source
European Union — EFSA
Subject to safety evaluation under Regulation (EC) No 1332/2008; EU Union list in development
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